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Cord Blood Transplantation in Adult Recipients

Phase 1/Phase 2
18 Years
70 Years
Not Enrolling
Hematologic Neoplasms

Thank you

Trial Information

Cord Blood Transplantation in Adult Recipients

The use of umbilical cord blood stem cells to treat blood disorders and cancer is an
important medical advance; currently, more than 45 disorders can be treated with this
method. While bone marrow transplants are the most common method for stem cell donations,
research has shown that there are many advantages to using allogeneic grafts of stem cells
obtained from umbilical cord blood. Cord blood stem cells are relatively easy to obtain.
Additionally, a perfect donor match is not necessary, thereby decreasing the likelihood of
graft-versus-host disease (GVHD), a serious side effect in which donor stem cells attack the
recipient's tissues. Cord blood has been used successfully in pediatric patients but its
benefit in adults remains untested. The purpose of this study is to evaluate the
effectiveness of umbilical cord blood stem cell transplantation in adults with advanced
blood disorders or cancer. Upon receiving an allogeneic stem cell transplant using umbilical
cord blood, participants will be observed for successful engraftment in which the
transplanted stem cells "take" and begin producing new blood cells. The incidence of GVHD
and the overall immune system's response will also be examined. In turn, these findings may
guide future umbilical cord blood stem cell clinical trials.

This 1-year study will enroll individuals with advanced blood diseases or cancer.
Participants will receive an allogeneic umbilical cord blood stem cell transplant and will
be closely monitored while in the hospital to determine when engraftment occurs and if GVHD
develops. Study visits will occur at Months 1, 2, 3, 6, 9, and Year 1. At each visit,
participants will have blood drawn for laboratory testing and for evaluation of immune
system response. Quality of life questionnaires will also be completed at each visit.

Inclusion Criteria:

- Diagnosis reviewed at transplant center and confirmed to fit the criterion for high
risk blood disease or cancer, as defined for the study

- Estimated life expectancy of at least 6 weeks following study entry

- Cancer and Leukemia Group B (CALGB) performance status less than or equal to 2

- White blood cell count, platelet, hematocrit, tuberculosis, aspartate
aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase,
creatinine, and HIV test results reviewed by transplant center

- Multiple gated acquisition (MUGA), echocardiogram, cardiac MRI, and/or pulmonary
function tests (PFT) performed and reviewed by transplant center (for individuals
with an ejection fraction and diffusing capacity [DLCO] of 40-50%, the appropriate
cardiology or pulmonary consultations should be considered if the individual has
severe heart or lung disease at the initiation of therapy)

- Sufficient number of umbilical cord blood units available for transplantation

- If female, willing to use contraception throughout the study

Exclusion Criteria:

- Undergoing Interleukin-2 (IL-2) therapy within 8 weeks of study entry

- Diagnosed with a medical or psychiatric illness that may interfere with study

- Pregnant

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Nelson J. Chao, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: Federal Government

Study ID:




Start Date:

January 2002

Completion Date:

May 2008

Related Keywords:

  • Hematologic Neoplasms
  • Hematological Malignancies
  • Leukemia
  • Lymphoma
  • Myelodysplasia
  • Multiple Myeloma
  • Neoplasms
  • Hematologic Neoplasms



Duke UniversityDurham, North Carolina  27710